Weaning is an important process to gradually separate mechanically ventilated patients from ventilators. A good weaning strategy aims to early identify mechanically ventilated patients who are ready for extubation but not to prematurely extubate them. Spontaneous breathing trial (SBT) is a test to assess the patient's ability to breathe spontaneously when extubated. Several methods have been used to conduct an SBT, including T-piece breathing, low-level pressure support ventilation (PSV) of 5-7 cm H2O, continuous positive airway pressure and automatic tube compensation (ATC). The investigators hypothesized that an SBT with inspiratory pressure augmentation increases initial SBT success, reduces the length of invasive mechanical ventilation (iMV) support and does not increase reintubation risk as compared with T-piece, which result in a higher proportion of patients successfully liberated from iMV in the inspiratory pressure augmentation group. However, inspiratory pressure augmentation significantly reduces work of breathing on an SBT as compared with T-piece. Patients extubated following an SBT with inspiratory pressure augmentation may experience increased respiratory effort after extubation and this may increase the use of noninvasive ventilation after extubation. An SBT with inspiratory pressure augmentation increases iMV free days but not MV free days as compared with T-piece. Longer iMV free days may be associated with a lower mortality due to fewer iMV related complication. This study is a pragmatic, cluster-randomized, multiple crossover, multicenter trial to compare SBTs with T-piece versus inspiratory pressure augmentation in weaning outcomes. Mechanically ventilated patients who meet the criteria for readiness to SBT will be included. The patients will use either T-piece or inspiratory pressure augmentation as SBT for weaning according to an ICU-based cluster randomization and crossover sequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,143
SBTs with T-piece breathing for one hour during odd-numbered months and SBTs with inspiratory pressure augmentation for one hour during even-numbered months.
SBTs with inspiratory pressure augmentation for one hour during odd-numbered months and SBTs with T-piece breathing for one hour during even-numbered months.
National Taiwan University Hospital
Taipei, Please Select, Taiwan
National Taiwan University Hospital Hsin-Chu Branch
Taoyuan District, Taiwan
National Taiwan University Hospital Yunlin Branch
Yunlin, Taiwan
Successful liberation from invasive mechanical ventilation
The primary study endpoint is to compare the effect of SBT with T-piece versus inspiratory pressure augmentation on the proportion of patients with successful liberation from invasive mechanical ventilation in the ICU among patients who have started an SBT. Successful liberation is defined as sustaining iMV free for at least five days after extubation.
Time frame: ICU discharge, up to 28 days after the initial SBT
Successful liberation from invasive and noninvasive mechanical ventilation
Proportion of successful liberation from invasive and noninvasive mechanical ventilation in the ICU.
Time frame: ICU discharge, up to 28 days after the initial SBT
Successful liberation from invasive mechanical ventilation
Proportion of successful liberation from invasive mechanical ventilation on day 28 from intubation.
Time frame: 28 days
Time to successful liberation from invasive mechanical ventilation
Time to successful liberation from invasive mechanical ventilation using competing-risks analysis.
Time frame: 28 days
Time to successful liberation from invasive and noninvasive mechanical ventilation
Time to successful liberation from invasive and noninvasive mechanical ventilation using competing-risks analysis.
Time frame: 28 days
Intubation free days
The number of days that a patient is alive and free from intubation.
Time frame: 28 days
Adjusted risk ratio of successful liberation from invasive mechanical ventilation
Adjusted risk ratio of successful liberation from invasive mechanical ventilation for T-piece versus inspiratory pressure augmentation group.
Time frame: ICU discharge, up to 28 days after the initial SBT
Initial SBT success
Proportion of initial SBT success among patients who have started an SBT.
Time frame: During the ICU stay, up to 28 days
Extubation failure
Proportion of extubation failure among patients undergoing planned extubation.
Time frame: Five days from extubation
Proportion of planned extubation
Proportion of planned extubation in the ICU
Time frame: ICU discharge, up to 28 days after the initial SBT
Use of noninvasive ventilation after extubation
Proportion of use of noninvasive ventilation (\>24 hours) after extubation.
Time frame: Five days from extubation
ICU mortality
Proportion of death in the ICU.
Time frame: ICU discharge, up to 28 days after the initial SBT
28-day mortality
Probability of death in 28 days using kaplan-meier estimator.
Time frame: 28 days
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